Uterine Manipulation in Surgery for Endometrial Cancer

(MAN-U Trial)

Recruiting at 3 trial locations

Overseen By Anthony Costales, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Anthony Costales, MD

Must not be taking: Progesterone

Disqualifiers: Laparotomic hysterectomy, Pelvic irradiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

278 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether using a uterine manipulator during minimally invasive surgery for early-stage uterine cancer affects the presence of cancer cells in surgical fluid. It compares surgeries performed with and without this device to identify any differences. Women diagnosed with early-stage uterine cancer who are not undergoing open surgery or specific therapies are suitable candidates. The study seeks to identify the safest and most effective surgical method for these patients. As an unphased trial, it offers patients the chance to contribute to important research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on progesterone therapy to treat endometrial cancer, you cannot participate in the trial.

What prior data suggests that the use of a uterine manipulator in surgery is safe?

Research has shown that using a uterine manipulator during minimally invasive surgery for endometrial cancer does not increase the risk of cancer recurrence. This finding supports the procedure's safety. However, studies have found an 11% chance of uterine perforation, a small hole or tear in the uterus, when using the manipulator. While this can be concerning, it often does not lead to long-term problems.

Overall, minimally invasive surgery is known for producing good results and is safe for most patients, including those who are older or have other health issues. Although the uterine manipulator carries some specific risks, research indicates that the overall procedure remains safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of using a uterine manipulator (UM) during minimally invasive surgery (MIS) for endometrial cancer. Typically, surgery for endometrial cancer does not always involve using a uterine manipulator. This trial aims to determine whether the addition of a uterine manipulator could improve surgical outcomes by enhancing the surgeon's ability to navigate and access the uterus more precisely. If successful, this could potentially lead to more effective surgeries with fewer complications and quicker recovery times for patients.

What evidence suggests that using a uterine manipulator in surgery is effective for early stage uterine cancer?

This trial will compare two surgical approaches for endometrial cancer: surgery with a uterine manipulator (UM) and surgery without a UM. Research has shown that using a uterine manipulator during less invasive surgery for endometrial cancer does not increase the risk of cancer recurrence. A review of several studies found no increase in cancer returning after surgery with a UM. However, one study found worse outcomes when a UM was used in patients whose cancer was confined to the uterus. The UM facilitates surgery and can enhance the surgeon's ability to operate. Overall, the evidence is mixed, but support exists that using a UM doesn't necessarily lead to worse outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Anthony Costales, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected early stage endometrial cancer, who are fit enough for minimally invasive surgery (MIS) and have no signs of cancer spread outside the uterus. They must be able to follow the study's procedures and not have had pelvic radiation or progesterone therapy for their cancer.

Inclusion Criteria

CA 125 testing is optional but, if obtained, must be within lab normal values

I can take care of myself and am up and about more than half of the day.

Signed informed consent and ability to comply with follow-up

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I am scheduled for a hysterectomy through an abdominal incision.

I am on progesterone therapy for my endometrial cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo minimally invasive surgery for early stage uterine cancer with or without a uterine manipulator

1 day

1 visit (in-person)

Immediate Post-operative

Assessment of positive peritoneal cytology and other surgical outcomes immediately after surgery

Immediately post-surgery

Follow-up

Participants are monitored for surgical morbidity and other outcomes up to 30 days post-surgery

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Surgery without UM
• Surgery with UM

Trial Overview The study compares outcomes in patients undergoing MIS for early stage uterine cancer using a uterine manipulator (UM) versus those without UM. It aims to see if there's a difference in the presence of cancer cells in surgical fluid between these two methods.

How Is the Trial Designed?

Group I: Surgery With UM (Arm MAN UA) Experimental Treatment 1 Intervention

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

Group II: Surgery Without UM (Arm Control) Active Control 1 Intervention

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

Surgery without UM is already approved in European Union, United States for the following indications:

Approved in European Union as Minimally Invasive Surgery for:

• Early-stage endometrial cancer

Approved in United States as Minimally Invasive Surgery for:

• Early-stage endometrial cancer

Who Is Running the Clinical Trial?

Anthony Costales, MD

Lead Sponsor

Trials

1

Recruited

280+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study comparing 86 robotic surgeries and 67 open surgeries for early-stage endometrial cancer, the use of a uterine manipulator in robotic surgery did not affect oncological outcomes such as recurrence or survival rates.

Robotic surgery resulted in longer operative times but significantly less blood loss, fewer complications, and shorter hospital stays compared to open surgery, indicating it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of a uterine manipulator in robotic surgery for early-stage endometrial cancer affect oncological outcomes? Ito, H., Moritake, T., Isaka, K.[2022]

In a survey of 165 French onco-gynecologic surgeons, only 42.7% routinely used the uterine manipulator (UM) during minimally invasive hysterectomies for endometrial cancer, with many surgeons (40.9%) avoiding its use due to concerns about the risk of tumor spillage.

Surgeons who did use the UM reported benefits such as reduced operating time (67.0%) and fewer complications (59.8%), but there remains significant variability in practice, highlighting the need for more prospective studies to assess the safety and efficacy of UM in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of uterine manipulator in endometrial cancer: A French survey from Francogyn group. Sallee, C., Lacorre, A., Despoux, F., et al.[2022]

In a study of 82 patients undergoing minimally invasive endometrial cancer surgery, a uterine perforation (UP) rate of 11% was observed, indicating a notable risk associated with the use of a uterine manipulator (UM).

While UP did not lead to any positive peritoneal cytology or recurrences, it was associated with a higher rate of lymph-vascular space invasion and resulted in changes to adjuvant therapies for 22% of patients, suggesting potential implications for treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of uterine manipulator and uterine perforation in minimally invasive endometrial cancer surgery. Sallée, C., Lacorre, A., Despoux, F., et al.[2023]

In a study of 2661 women with early-stage endometrial cancer, the use of a uterine manipulator during minimally invasive surgery was linked to a higher recurrence rate of 11.69% compared to 7.4% in those who did not use the manipulator, indicating a potential risk associated with its use.

The presence of a uterine manipulator was also associated with lower disease-free survival and a higher risk of death, suggesting that its use may negatively impact oncological outcomes for patients with uterus-confined endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. Padilla-Iserte, P., Lago, V., Tauste, C., et al.[2021]

The use of uterine manipulators during minimally invasive surgery for endometrial cancer does not increase the risk of positive peritoneal cytology, lymphovascular space invasion (LVSI), or recurrence, based on a meta-analysis of 11 studies.

The timing of uterine manipulator insertion also showed no significant impact on these outcomes, suggesting that their use is safe in the context of laparoscopic surgery for endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of uterine manipulators in minimally invasive hysterectomy for endometrial cancer: A systematic review and meta-analysis. Meng, Y., Liu, Y., Lin, S., et al.[2020]

The use of uterine manipulators (UM) during laparoscopic total hysterectomy for early-stage endometrial cancer (EC) is generally considered safe, as supported by a review of 11 eligible studies.

While all types of UMs are deemed fairly safe, their application should be customized based on the tumor's size and the extent of myometrial infiltration to minimize risks such as iatrogenic lymphovascular space invasion (LVSI) and retrograde tumor spillage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of uterine manipulator during laparoscopic endometrial cancer treatment. Capozzi, VA., Rosati, A., Uccella, S., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074879832200484X

Influence of uterine manipulator on oncological outcome in ... This meta-analysis supports that the use of uterine manipulator for minimally invasive treatment of endometrial cancer does not increase the rate of recurrence ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32693096/

Impact of uterine manipulator on oncological outcome in ... In this study, the use of a uterine manipulator was associated with a worse oncological outcome in patients with uterus-confined endometrial cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12208720/

Minimally Invasive Surgery in Endometrial Cancer MIS was found to have superior outcomes for low-risk endometrial cancer and a comparable safety for high-risk patients, including those with older age or ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798320303723

The effects of uterine manipulators in minimally invasive ... Our study systematically reviewed the surgical results for the effects of UM in MIS hysterectomy among patients with endometrial cancer. In the current meta- ...

5. tcr.amegroups.org tcr.amegroups.org/article/view/41996/html

Role of uterine manipulator during laparoscopic endometrial ... The uterine manipulator (UM) represents a valuable tool in order to increase the ergonomics of surgical gesture during a laparoscopic total hysterectomy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37301478/

Use of uterine manipulator and uterine perforation in ... Our study found a uterine perforation rate of 11%. This information needs to be further integrated to consider the usefulness of MU for EC surgery.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468784723000880

Use of uterine manipulator and uterine perforation in ... Summary of main results ... This prospective cohort study shows a UP rate of 11% among the 82 patients undergoing surgery for endometrial cancer while using a UM.

8. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)00726-1/pdf

Uterine manipulation during minimally invasive surgery for ... This study aimed to compare oncologic outcomes for patients undergoing minimally invasive surgery (MIS) versus laparotomy for. 2009 International Federation of ...